Professional Diploma in Clinical Research, CDM, SAS, Pharmacovigilance, Medical and Regulatory Writing

Six Sigma Academy of Clinical Research
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Important information

  • Diploma
  • Duration:
    3 Months
Description


Suitable for: Graduates from Science Background

Important information

Course programme

Six sigma academy of clinical research offers professional diploma in clinical research ,CDM,SAS,pharmacovigilance,regulatory and medical writing. All courses are delt by industry experts from cognizant, accenture, Icon and Parexel. Six sigma academy is a service partner of six sigma bio solutions Pvt.Ltd., a Contract Research Organisation (CRO) offering services for pharma,biotech and healthcare industries in medical writing & scientific communications,regulatory writing, clinical trial operations,staffing solutions,corporate training. Six sigma academy offer professional diploma in clinical research with highest quality provided by faculty from industry (usa,uk,europe) with sophisticated lab facility with limited batch size. MODULE I:CLINICAL RESEARCH -- DRUG DISCOVERY AND DEVELOPMENT -- PRECLINICAL STUDIES -- BASICS OF CLINICAL TRIALS & CLINICAL RESEARCH -- TERMINOLOGY & DEFINITIONS IN CLINICAL TRIALS -- TYPES AND PHASES OF CLINICAL TRIALS -- GOOD CLINICAL PRACTICES (GCP) -- CLINICAL TRIAL STATISTICS (BIOSTATS) -- BA/BE STUDIES -- RESEARCH METHODOLOGY&CLINICAL TRIAL DESIGN -- CLINICAL TRIAL REGULATORY AFFAIRS -- BIOETHICS -- PREPARATIONS & PLANNING FOR CLINICAL TRIALS -- ESSENTIAL DOCUMENTATION IN CLINICAL TRIALS & REGULATORY SUBMISSIONS -- CLINICAL TRIAL OPERATIONS AND MONITORING -- RESPONSIBILITIES OF CLINICAL RESEARCH PROFESSIONALS -- 21 CFR 11 -- INTRODUCTION TO CDISC -- INFORMED CONSENT FORM -- SCHEDULE Y -- PROTOCOL DEVELOPMENT -- INTELLECTUAL PROPERTY RIGHTS (IPR) AND PATENT LAWS MODULE II: CLINICAL DATA MANAGEMENT -- INTRODUCTION TO DATABASE -- DATA MANAGEMENT PLAN -- EDC (ELECTRONIC DATA CAPTURE) -- CRF DESIGN (PAPER) -- E-CRF DEVELOPMENT -- REPORT CREATION AND DATA TRANSFER -- DATA CLEANING -- STUDY LOCKING -- OPEN CLINICA (COMPREHENSIVE THEORY AND PRACTICAL) -- ORACLE CLINICAL , RAVE,INFORM,MEDRIO (OVERVIEW) -- SYSTEM VALIDATION MODULE III: SAS -- SAS 9.1.3 / SAS 9.2 -- SAS/BASE -- SAS/STAT -- SAS/PROCEDURES -- SAS/ACCESS -- SAS/SQL -- SAS/GRAPH -- SAS/MACROS -- SAS ENTERPRISE GUIDE 4.1 MODULE IV: PHARMACOVIGILANCE -- OVERVIEW OF PHARMACOVIGILANCE -- REGULATORY ASPECTS IN PHARMACOVIGILANCE -- PERIODIC SAFETY UPDATE REPORTS (PSUR’S) -- SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS -- CASE REPORT PROCESSING -- EUDRA VIGILANCE -- SIGNAL DETECTION PROCESS AND TOOLS -- SAFETY INTELLIGENCE -- OVERVIEW OF PHARMACOVIGILANCE S/W MODULE V: MEDICAL, SCIENTIFIC AND REGULATORY WRITING -- INTRODUCTION TO MEDICAL WRITING -- MANUSCRIPT WRITING -- SCIENTIFIC SLIDES -- BRANDING AND COMMERCIAL WRITING -- GRANT WRITING -- PATIENT NARRATIVES -- INTRODUCTION TO REGULATORY WRITING -- INVESTIGATOR BROCHURE (IB) PREPARATION -- CLINICAL STUDY REPORTS (CSR) -- PROTOCOL WRITING -- COMMON TECHNICAL DOCUMENT (CTD/ ECTD PREPARATION -- DOSSIER SUBMISSIONS (IND/NDA/ANDA) -- ICF TRANSLATIONS Call us for more info @ 9989021111 E-mail us : sixsigmabioacademy@gmail.com training@sixsigmabioacademy.com

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